Transition Period (FY 2007)

The FY 2007 cohort served as a transition period from MDUFMA I to MDUFA II as many submissions received in FY 2007 (during MDUFMA I) were acted on or due for action in FY 2008 (during MDUFA II). FDA will continue to report on MDUFMA I decision goals for submissions received in FY 2007 until performance can be reported as final. FY 2007 decision goals for standard original biologics licensing applications (BLAs) and BLA manufacturing supplements that require prior approval had final performance reported in the FY 2008 MDUFA Performance Report and, therefore, are not included in this, or future, MDUFA performance reports.

Performance for FY 2007

The table below finalizes FDA’s performance on the MDUFMA I cohort for FY 2007 as of September 30, 2009. Overall, FDA met or exceeded 3 of 5 performance goals for FY 2007.

PMAs, Panel-Track Supplements, and Premarket Reports. FDA completed 54 percent (20 of 37) of reviews (to make a decision within 180 days) on time and exceeded the 50 percent performance goal. FDA completed 87 percent (32 of 37) of reviews (to make a decision within 320 days) on time and did not meet the 90 percent performance goal.

Expedited PMAs. FDA did not complete either of the two reviews on time and did not meet the 90 percent performance goal.

510(k)s. FDA completed 91 percent (2,940 of 3,238) of reviews on time and exceeded the 80 percent performance goal.

PMAs, Panel-Track Supplements, and Premarket Reports

Goals

Review Within

Cohort Closed

Received*

Final Performance

Overdue

On Time

PercentOn Time

Performance Goal

Make an “FDA decision”

180 days

N

37

17

20

54%

50%

320 days

N

37

5

32

87%

90%

Expedited PMAs

Goals

Review Within

Cohort Closed

Received*

Final Performance

Overdue

On Time

PercentOn Time

Performance Goal

Make an “FDA decision”

300 days

Y

2

2

0

0%

90%

180-day PMA Supplements

Goals

Review Within

Cohort Closed

Received*

Final Performance

Overdue

On Time

PercentOn Time

Performance Goal

Make an “FDA decision”

180 days

Y

142

12

130

92%

90%

510(k)s

Goals

Review Within

Cohort Closed

Received*

Final Performance

Overdue

On Time

PercentOn Time

Performance Goal

Make a SE or NSE decision

90 days

N

3,238

298

2,940

91%

80%

* The data shown for 510(k)s received represents the MDUFMA cohort. The MDUFMA cohort for 510(k)s excludes submissions that were closed for any reason other than an SE or NSE decision. Each MDUFMA cohort count is subject to change until that cohort is closed.